FDA Reviewing Lantus (Synthetic Insulin) Cancer Risks

Just days after new research found the synthetic insulin product Lantus may increase the risks of developing certain cancers, the Food and Drug Administration said it is reviewing data on the safety of the drug.

Lantus is a once-a-day insulin injection available by prescription and known generically as glargine. It reportedly generated 2008 sales of $3.45 billion for its maker, Sanofi-Aventis.

The FDA announced today that it is looking into the recently released studies and other data to determine whether more research on its safety should be done. The length of time in which Lantus users in the studies required follow-up treatment was shorter than what the FDA considers necessary to evaluate cancer risks from drug exposure, the agency said.

“Further, inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists,” the FDA said, according to a report in The Wall Street Journal.

The FDA cautioned, however, that diabetics taking Lantus should not stop taking their insulin without first consulting a doctor. Stopping use of insulin can result in severe and potentially deadly medical complications, the agency said.

New Research Cited by FDA

Earlier this week, international researchers said they had determined that people using Lantus were as much as twice as likely to develop various cancers compared to diabetics not taking the drug. However, the research was quickly criticized and questioned by the American Diabetes Association and others who dubbed the findings “conflicting and inconclusive.”

The FDA said it will announce findings from its review as the work to evaluate Lantus continues.

No related posts.